Team:Aix-Marseille/Legislation

Legislation

We initiated research on legislation about lab safety and bioproducts marketing. Both lab work and production of our solution need to be conform with the law. It means that everything used in the lab have to comply with legal safety measures and as well as our solution . Moreover, since synthetic biology is about modifying nucleic acids, the legislation about GMOs has to be considered.

Research and legislation

Research ensures innovation, access to new markets and competitivity in the global marketplace. The French legislation establishes very few barriers in this field. This enable scientists to carry out their work with minimal constraints. Genetically Modified Organisms (GMOs) research field is regulated by articles L241-1 to L241-3 of the French Research Code.
All the experimentation conducted during our wet lab was authorized under this legislation.

Marketing authorization

Regulatory framework for the release of KILL XYL into the market (Diagram from EFSA).

One of the components of our product, the phage-like particle, is a GMO according to the EC Directive of the 12 March 2001. This qualification as a GMO has many consequences for the market release of KILL XYL.

A plant protection product needs to be authorised in accordance with the EC rule of the 21 October 2009. For products containing a GMO, an authorization under this rule can only be granted if the GMO is authorize under Article 19 of Directive 2001/18/EC. The authorization procedure for the GMO can be found on the European Food Safety Authority website (EFSA).

The first step in obtaining authorization is to send a notification to the competent national authority (for France: the Minister of Research).

According to the Directive 2001/18/EC, the notification must contain a great deal of information, including:

  • the phenotypic and genetic characteristics of the GMO;
  • the verification of the genetic stability of the GMO and factors affecting this stability;
  • organisms with which genetic transfer is known to occur naturally;
  • an environmental impact study.

Some of these questions have been answered with our environmental test.

The (EFSA) then draws up an evaluation report which indicates whether or not the GMOs can be placed on the market and under which conditions. Once the GMO authorization has been obtained, the applicant can then submit his application for authorization of the plant protection product to the "Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail" (ANSES) containing information on all the components of the product.

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